丙型肝炎病毒核心抗原在血液透析患者中的检测和应用

Detection of hepatitis C virus antigen in hemodialysis patients

目的探讨丙型肝炎病毒核心抗原酶联免疫吸附法在血液透析患者HCV感染检测中的应用。方法对本院250名血液透析患者，用第三代酶联免疫吸附试剂盒检测抗一HCV抗体、酶联免疫吸附法检测HCV核心总抗原，用巢式RT-PCR法对阳性标本进行确认。结果250例血液透析患者中抗-HCV抗体阳性43例（阳性率17．2％），HCV—cAg阳性45例（阳性率18％），经配对x^2检验，P=0．839，差异无统计学意义；43例抗-HCV抗体阳性中RT-PCR检测结果为36例HCV—RNA阳性，其中32例HCV—cAg也呈阳性，另外4例HCV-cAg阴性；45例HCV-cAg阳性标本中HCV—RNA结果全阳性；13例核心抗原阳性但抗体阴性的患者样本中也含有HCV—RNA，抗-HCV抗体的漏检率为23．2％（13／56）；核心抗原阳性标本测出病毒载量是（49258±28682）拷贝／ml，高于抗-HCV抗体阳性组（23938±10780）拷贝／ml（P〈0．05）；4例核心抗原阴性但抗-HCV抗体及RT-PCR均阳性标本的病毒载量是（306±161）拷贝/ml，明显低于HCV核心抗原阳性组（P〈0．001）。结论HCV核心总抗原酶联免疫吸附试验将有益于由于免疫抑制状态、窗口期更长的血液透析患者，与抗-HCV的检测结果具有互补性；HCV—cAg能很好反映HCVRNA，相对于PCR来说，HCV-cAg检测既具有成本效益好又可减少人力资源，具有广阔的临床应用前景。

Objective To investigate the utility of the HCV core antigen ELISA in the detection of HCV infection in hemodialysis patients and to compare with Anti-HCV antibodies 3rd generation ELISA. Methods Two hundred fifty hemodialysis patients were included in the study. Anti-HCV antibodies and total HCVcAg was determined by ELISA kits. HCV RNA was determined using reverse transcriptase polymerase chain reaction （RT- PCR） .Results Forty-three out of 250 （17.2%） patients were positive for anti-HCV antibodies and 18% WERE positive for HCVcAg. 13/250 （5.2%） were positive for HCVcAg but anti-HCV negative, All 13 were confirmed viremic by in-house nested RT-PCR leading to specificity of 100% . Viral load of （49258 ± 28682） copies/ml were detected in HCVeAg positive cases was higher in comparison to （23938 ± 10780） copies/ml in the anti-HCV positive group （P 〈 0.05）. The viral load of 4 negative cases for HCVeAg assay but anti-HCV positive was 306 ± 161 capies/ml which was significantly lower in comparison to HCVcAg positive group （ P 〈 0.001 ）. Conclusion Detection of total HCVcAg together with anti-HCV will be useful for patients undergoing hemodialysis who have a longer window period due to immunosuppressed state. HCVcAg was compatible for the HCV RNA in serum and total HCVcAg ELISA is both a cost-effective and a less labor-intensive alternative to PCR, enhancing its clinical utility.